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GSK plc announced that the China National Medical Products Administration has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5), as an add-on…
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Astellas Pharma Inc. announced that China's National Medical Products Administration (NMPA) has approved VYLOY™ (zolbetuximab), in combination with fluoropyrimidine- and…
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Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with locally advanced or metastatic epidermal…
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GSK plc announced the US Food and Drug Administration (FDA) has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for…
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The US Food and Drug Administration has granted Fast Track designation to two Sanofi combination vaccine candidates to prevent influenza and COVID-19 infections in individuals 50 years…
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Ipsen and Biomunex Pharmaceuticals announced an exclusive global licensing agreement for BMX-502. BMX-502 is a bispecific antibody that engages and activates a subset of cytotoxic T…
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Eli Lilly and Company announced topline results from the SURMOUNT-5 phase 3b open-label randomized clinical trial. Zepbound (tirzepatide) provided a 47% greater relative weight loss…
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Takeda announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. to further develop, manufacture and commercialize elritercept worldwide outside…
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Roche announced today that it has entered into a definitive merger agreement to acquire Poseida Therapeutics, Inc., a public clinical-stage biopharmaceutical company pioneering…
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Amneal Pharmaceuticals, Inc. announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and Drug Administration (FDA) its new drug…
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Samsung Biologics announced a series of manufacturing deals with a Europe-based pharmaceutical company. The disclosed deals, worth over USD 668 million combined, will run through…
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AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of…
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QIAGEN announced a collaboration with the McGill University Centre for Microbiome Research to support microbiome research activities and outcomes. The three-year partnership will…
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GSK announced that Health Canada has approved Ojjaara (momelotinib) for the treatment of splenomegaly and/or disease-related symptoms, in adult patients with intermediate or high-risk…
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The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers…
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GSK’s AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by…
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Ascendis Pharma A/S announced that it has granted Novo Nordisk A/S an exclusive worldwide license to the TransCon technology platform to develop, manufacture and commercialize Novo…
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GSK plc and Chimagen Biosciences (Chimagen), a privately held biotechnology company, announced an agreement for GSK to acquire CMG1A46, a clinical-stage dual CD19 and CD20-targeted T…
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Novartis announced that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia…
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AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with…
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